Vasomotor Symptoms Associated With MenopausePhase 1/2NCT07118891
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
A Phase 1/2 study testing ABCL635 in people with Vasomotor Symptoms Associated With Menopause and Healthy Volunteers, run by AbCellera Biologics Inc. at 13 sites in Canada.
Trial summary
The purpose of this study is to evaluate the effects of single and multiple doses of ABCL635 administered by subcutaneous (SC) injection to healthy men and to postmenopausal women with or without any vasomotor symptoms (VMS) or hot flashes, and to postmenopausal women with moderate-to-severe VMS associated with… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
- What is being tested?
- ABCL635
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 13 sitesCanada
- Study dates
- 23 Jun 2025to Feb 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health as determined through a review of their medical history and after conducting a general physical examination
- Body weight ≥ 45 to ≤ 120 kg
- Body mass index (BMI) between 18.5 kg/m2 and 35.0 kg/m2
- Non- or ex-smoker (an ex-smoker is defined as someone who completely stopped using nicotine products for at least 90 days prior to the first study drug administration)
- Healthy man or a postmenopausal woman who is ≥ 40 and ≤ 75 years of age OR a postmenopausal woman with or without VMS and who is ≥ 40 and ≤ 75 years of age OR a postmenopausal woman who is ≥ 40 and ≤ 75 years of age seeking treatment for relief for VMS
- If a woman:
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- has been compliant with local and/or national guidelines for breast cancer screening with documentation of a mammogram with normal/negative or no clinically significant findings. A screening mammogram may be conducted during study screening period, if needed
- has spontaneous amenorrhea for at least 12 consecutive months; or spontaneous amenorrhea for at least 6 months with biochemical criteria of menopause (follicle-stimulating hormone [FSH] > 40 IU/L); or had a bilateral oophorectomy > 6 weeks prior to screening, or s/p hysterectomy at least 6 weeks prior to screening and meeting the biochemical criteria of menopause (FSH > 40 IU/L)
- If a man:
- possess a testosterone concentration of ≥ 15 nmol/L at the time of screening
- can procreate and agree to use one of the acceptable contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration OR is unable to procreate; defined as surgically sterile
Who cannot join
- Pregnancy and/or lactation.
- Has endometrial hyperplasia or history of abnormal uterine bleeding without an identified cause in the past 6 months
- Previous or current history of a malignant tumor, except for non-melanoma skin cancer.
- Seated pulse rate less than 50 beats per minute (bpm) or more than 100 bpm or a seated blood pressure < 90/50 mmHg or > 140/90 mmHg
- eGFR < 60 mL/min/1.73 m2
- Severe hypersensitivity reactions (like angioedema) to any drugs.
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- Significant uncontrolled cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease.
- Clinically significant ECG abnormalities
- Presence or history of cardiogenic syncope in the past 6 months.
- Use of any over-the-counter products (including supplements) containing testosterone or any medication (hormonal, prescription, over the counter, herbal, or natural) for the treatment of hot flashes during the screening period and throughout the study; must be discontinued at least 28 days prior to study drug administration
- Employees of the sponsor or the investigator site and other individuals who are directly involved in the conduct of the study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
CaRe Clinics
Calgary, Alberta, T2N 4L7
Alpha Recherche Clinique
Lévis, Quebec, G6V 0C9
GCP Research
Montreal, Quebec, H1Y 3H5
Altasciences Company Inc.
Mount Royal, Quebec, H3P 3P1
Clinique RSF Inc.
Québec, Quebec, G1V 3M8
Diex Recherche Québec
Québec, Quebec, G1V 4T3
CaRe Clinics
Red Deer, Alberta, T4P 1K4
Diex Recherche Sherbrooke
Sherbrooke, Quebec, J1L 0H8
Centricity Research
Toronto, Ontario, M4G 3E8
Centricity Research
Toronto, Ontario, M4W 4L6
Diex Recherche Trois-Rivières
Trois-Rivières, Quebec, GSA 4P3
Mount Saint Joseph Hospital Clinical Trials Phase 1 Unit
Vancouver, British Columbia, V5T 3N4
Diex Recherche Victoriaville
Victoriaville, Quebec, G6P 3Z8
About this study
Official title: A First-in-Human Phase 1/2 Study of ABCL635 in Healthy Participants and in Postmenopausal Women With Moderate-to-Severe Vasomotor Symptoms
The purpose of this study is to evaluate the effects of single and multiple doses of ABCL635 administered by subcutaneous (SC) injection to healthy men and to postmenopausal women with or without any vasomotor symptoms (VMS) or hot flashes, and to postmenopausal women with moderate-to-severe VMS associated with menopause. The safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) parameters of ABCL635 will be assessed in all study participants; the effects on frequency and severity of VMS will be assessed in postmenopausal women who experience moderate-to-severe symptoms.
Read the detailed description
The study consists of 3 parts: Part A and Part B (Phase 1) and Part C (Phase 2). In Part A, single ascending doses (SAD) of ABCL635 or placebo will be administered to healthy male and female participants. In Part B, up to 3 multiple ascending doses (MAD) of ABCL635 or placebo will be administered to healthy postmenopausal women with or without VMS. In Part C, a single dose of ABCL635 or placebo will be administered to postmenopausal women experiencing moderate-to-severe VMS associated with menopause. In Part C, all participants will be offered to participate in an open label extension (OLE) cohort and receive a single dose of ABCL635 upon completion of a 12-week assessment.
- Being tested
- ABCL635, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABCL635Biological
Participants will receive SC administrations of ABCL635
PlaceboBiological
Participants will receive SC administration of placebo (5% dextrose solution)
| Study group | Role | What they receive |
|---|---|---|
| ABCL635 Part A | Experimental | Part A: healthy male and female participants will receive a single dose of ABCL635 administered by subcutaneous (SC) injection Receives: Biological: ABCL635 |
| Placebo Part A | Placebo comparator | Part A: Healthy male and female participants will receive a single dose of placebo (dextrose 5% solution) administered by SC injection Receives: Biological: Placebo |
| ABCL635 Part B | Experimental | Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of ABCL635 administered by SC injection Receives: Biological: ABCL635 |
| Placebo Part B | Placebo comparator | Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of placebo (dextrose 5% solution) administered by SC injection Receives: Biological: Placebo |
| ABCL635 Part C | Experimental | Part C: postmenopausal women with moderate to severe VMS will receive a single dose of ABCL635 administered by SC injection Receives: Biological: ABCL635 |
| Placebo Part C | Placebo comparator | Part C: postmenopausal women with moderate to severe VMS will receive a single dose of placebo (dextrose 5% solution) administered by SC injection Receives: Biological: Placebo |
| ABCL635 Part C OLE | Experimental | Part C open label extension (OLE): postmenopausal women with moderate to severe VMS will receive a single dose of ABCL635 administered by SC injection upon completion of 12-week assessment. Receives: Biological: ABCL635 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events (AE)
Measured: Day 0 to day 197
Number of participants with abnormalities in 12-lead safety electrocardiograms (ECG)
Measured: Day 0 to day 197
Number of participants with abnormalities in physical examination
Measured: Day 0 to day 197
Number of participants with abnormalities in laboratory parameters, including general biochemistry, hematology, endocrinology, and urinalysis
Measured: Day 0 to day 197
Secondary outcomes (20)
Mean change from baseline to each study week in the frequency of moderate and severe VMS (VMSM-S frequency)
Measured: up to day 141 (Part C)
Mean change from baseline to each study week in the severity of moderate and severe VMS (VMSM-S severity)
Measured: up to day 141 (Part C)
Mean change from baseline to each study week in the frequency of all reported VMS (VMSTotal frequency).
Measured: up to day 141 (Part C)
Mean change from baseline to each study week in the moderate to severe hot flash score (HFM-S).
The moderate to severe hot flash score (HFM-S) is a metric that combines the frequency and severity of hot flashes:
- The daily score is calculated as follows: (number of moderate hot flashes x 2) + (number of severe hot flashes x 3)
- The weekly score is the average daily score over seven days. A negative change in the score from Baseline to Week 1 indicates a reduction in the severity and frequency of hot flashes
Measured: up to day 141 (Part C)
Mean change from baseline to each study week in the total hot flash score (HFTotal).
The total hot flash score (HFTotal) is a metric that combines the frequency and severity of hot flashes:
- The daily score is calculated as follows: (number of mild hot flashes x 1) + (number of moderate hot flashes x 2) + (number of severe hot flashes x 3)
- The weekly score is the average daily score over seven days. A negative change in the score from Baseline to Week 1 indicates a reduction in the severity and frequency of hot flashes.
Measured: up to day 141 (Part C)
Mean change in the Menopause-Specific Quality of Life Questionnaire (MENQOL) 4-domain scores (ie, physical, vasomotor, psychosocial, and sexual) from baseline to weeks 1, 2, 3, 4, 5, 9, and 13
The Mean change in the Menopause-Specific Quality of Life Questionnaire (MENQOL) measures the impact of menopause symptoms over the last week.
The questionnaire has 29 items across four domains: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26), and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a 0 (not bothersome) to 6 (extremely bothersome) scale.
The mean change in the MENQOL domain scores will be assessed from Baseline to each week measured. A negative change in the score from Baseline to each week measured indicates an improvement in quality of life.
Measured: up to day 141 (Part C)
Mean change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance 8b Short Form (PROMIS-SD-SF-8b) total score from baseline to weeks 1, 2, 3, 4, 5, 9, and 13.
The PROMIS-SD-SF-8b assesses the perception of sleep quality, sleep depth, and any perceived difficulties related to getting and staying asleep. Questions are scored using the following scale: 1 (very much), 2 (quite a bit), 3 (somewhat), 4 (a little bit), and 5 (not at all).
The mean change in the PROMIS-SD-SF-8b score will be assessed from Baseline to each week measured. A positive change in the score from Baseline to each week measured indicates a reduction in sleep disturbance.
Measured: up to day 141 (Part C)
Frequency of Patient Global Impression of Change in VMS (PGI-C VMS) responses at weeks 2, 3, 4, 5, 9, and 13.
The Patient Global Impression of Change (PGI-C) for vasomotor symptoms (VMS) rates the perception of their hot flashes and night sweats at each designated timepoint compared to the start of the study. The response is a seven-point scale ranging from "much better" to "much worse." The frequency of each PGI-C VMS score will be reported at each scheduled timepoint.
Measured: up to day 141 (Part C)
Plasma concentrations of ABCL635
Measured: Day 0 to day 197
Incidence of anti-ABCL635 antibodies
Measured: Day 0 to day 197
PK parameters; maximum plasma concentration (Cmax)
Measured: Day 0 to day 197
PK parameters; time to maximum plasma concentration (Tmax)
Measured: Day 0 to day 197
PK parameters; area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-T)
Measured: Day 0 to day 197
PK parameters; area under the plasma concentration-time curve from zero to hour 672 (AUC0-672)
Measured: Day 0 to day 197
PK parameters; area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
Measured: Day 0 to day 197
PK parameters; percent of AUC obtained by extrapolation (%AUCextrap)
Measured: Day 0 to day 197
PK parameters; terminal rate constant (λz)
Measured: Day 0 to day 197
PK parameters; apparent plasma clearance of drug after extravascular administration (CL/F)
Measured: Day 0 to day 197
PK parameters; apparent volume of distribution after extravascular administration (Vz/F)
Measured: Day 0 to day 197
PK parameters; half-life (Thalf)
Measured: Day 0 to day 197
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start23 Jun 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor Symptoms Associated With MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbCellera Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, Principal investigator, Altasciences Company Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118891
- Sponsor's protocol ID
- ABCL635-101
- Other IDs
- 297103
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No